Gilead Warned By Democrats Over 'Quad' Pricing

English: The Red ribbon is a symbol for solidarity with HIV-positive people and those living with AIDS. Français : Le Ruban rouge, symbole de la solidarité avec les personnes séro-positives. (Photo credit: Wikipedia)

In an effort to get ahead of the curve on what may be a hot pricing issue, more than a dozen Democratic members of Congress have written Gilead Sciences to caution the drugmaker to maintain a reasonable price for its forthcoming ‘Quad’ AIDS drug. The once-a-day treatment was recently recommended by an FDA panel and may be approved by the agency this month. In their letter, the 14 congressional representatives express concern that Gilead may charge as much as $34,000 for Quad, which they say could further strain state AIDS funding programs.

How so? They note that Gilead froze prices through 2013 for drugs provided to ADAPs, or AIDS Drug Assistance Programs, run by the states. But at the same time, the drugmaker boosted prices for its meds in the commercial market: a 7.9 percent increase on Truvada, a 7.3 percent increase for Complera and a 6.6 percent increase on Atripla, which raises costs for privately insured and Medicare patients.

“As a result, Ryan White Part B programs that help these patients afford their co-pays and deductibles now face overwhelming demand and have instituted waiting lists. Given that Ryan White Part B funds both the co-pays and deductibles of privately insured patients as well as ADAP, price increases for antiretroviral drugs in the commercial market diminish the ability of ADAPs to purchase drugs and sustain their case loads,” they write to Gilead.

“Without more affordable HIV/AIDS drugs, we fear that Ryan White Part B-funded co-pays and deductibles will continue to rise, leaving less funding available for ADAP and thousands of our most vulnerable constituents untreated. Therefore, we urge Gilead to consider sustainable pricing strategies for its products that would help allow ADAP to provide treatment to as many individuals as possible,” they urge Gilead ceo John Martin (this is the letter).

They go on to maintain that, if Quad is priced between $27,000 and $34,000 per patient, this would represent a 38 percent premium above Atripla, another Gilead drug that is the most commonly used HIV combination treatement. And they expect Quad to become a widely used first-line therapy, since it consists of a single-tablet regimen and lacks neuropsychiatric side effects. Consequently, they calculate such pricing and usage would pressure ADAP programs.

As of August 9, there were 1,125 individuals on ADAP waiting lists in seven states, according to the National Alliance of State & Territorial AIDS Directors. This is a 63 percent drop from April. Nonetheless, 21 ADAPs, including seven with current waiting lists, have instituted additional cost-cutting steps over the past three years and two ADAPs are considering new or additional measures by March 2013 (you can read more here).

A Gilead spokeswoman declined to comment on the pricing, since the drug is not yet commercially available. If approved by the FDA, the Quad treatment would be used by people living with HIV who are starting treatment for the first time. The drug actually includes four medications – Viread; Emtriva; an experimental integrase inhibitor known as elvitegravir, and cobicistat, which is actually not an HIV medication, but can boost the utility of elvitegravir.

One advocacy group praised the move to draw attention to pricing even before the drug is available. “It would be unconscionable but, sadly, not entirely unexpected, if Gilead priced the Quad higher than similar drugs already on the market, particularly when the Quad is only a marginal improvement over other existing medications,” says AIDS Healthcare Foundation president Michael Weinstein, in a statement. “In the long run, the cost to Gilead to actually produce the Quad will be a small fraction of its selling price, which means Gilead can show restraint on Quad pricing and still make an enormous profit.”

I've followed the pharmaceutical industry since 1995. This ride began at The Star-Ledger of New Jersey and continues with Pharmalot, which I have run since 2007. Along the way, I was also an editor at The Pink Sheet. Before covering pharma, I worked for several years at New ...